Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery

Recruiting

• Conditions: Allografts; Tricuspid Valve Insufficiency
• Interventions: Procedure: Mitral allograft implantation

• Registration Number: NCT06196684
• Lead Sponsor: Chelyabinsk Regional Clinical Hospital

Brief Summary

The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.

Detailed Description

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with mid-term clinical efficacy ( mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication ) is going to be evaluated.

Study Timeline

• Study Start: 2021-09-29
• Status Verified: 2023-12
• Study First Submitted: 2023-12-26
• Study First Submitted QC: 2023-12-26
• Last Update Submitted: 2023-12-26
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-09-29
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.
• Intraoperative findings suggested for tricuspid valve replacement rather than repair.

Exclusion Criteria

• Pregnancy
• Confirmed active drug addiction
• Progressive HIV-infection
• HIV-infected patients with CD4-cells count less than 250
• Patients with secondary tricuspid valve pathology (left-sided valve disease)
• LV Ejection fraction less than 50%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with primary tricuspid valve insufficiency scheduled for tricuspid valve replacement	Mitral allograft implantation	-

Primary Outcome Measures

Name	Time	Method
Mortality (all cause and valve-related)	30-day period	Estimate rate of mortality (all cause and valve-related)

Secondary Outcome Measures

Name	Time	Method
Cardiac structural complications	30 days	any structural cardiac complication
Acute kidney injury	30 days	freedom from type 3-4 AKI
Allograft valve dysfunction	30 days	freedom from allograft valve stenosis or regurgitation
Neurologic events	30-day period	any neurological events in 30-day period
Bleeding and transfusions	30 days	Freedom from major bleeding events

Trial Locations

Locations (1)

Department of Cardiac Surgery; 🇷🇺 Chelyabinsk, Russian Federation